Core Insights - CG Oncology, Inc. reported positive results from the Phase 3 BOND-003 trial, highlighting the durability and tolerability of cretostimogene for bladder cancer treatment [2][6] - The company plans to submit a Biologics License Application (BLA) for cretostimogene in Q4 2025, targeting high-risk non-muscle invasive bladder cancer (NMIBC) patients unresponsive to BCG [2][11] - A recent legal victory against ANI Pharmaceuticals allows CG Oncology to focus resources on developing cretostimogene without future royalty obligations [2][5] Financial Highlights - For Q2 2025, CG Oncology reported a net loss of $41.4 million, or $0.54 per share, compared to a net loss of $18.9 million, or $0.28 per share in Q2 2024 [11][14] - Research and development expenses increased to $31.3 million in Q2 2025 from $18.5 million in Q2 2024, primarily due to higher clinical trial costs and increased headcount [11][14] - General and administrative expenses rose to $17.4 million in Q2 2025 from $7.5 million in Q2 2024, attributed to personnel-related costs and legal expenses [11][14] Cash Position - As of June 30, 2025, CG Oncology had cash and cash equivalents of $661.1 million, down from $688.4 million as of March 31, 2025 [11][16] - The company expects its current cash position to fund operations into the first half of 2028 [11] Clinical Development Updates - The company presented best-in-disease durability data from the BOND-003 trial, showing a 75.5% complete response rate at any time and a median duration of response of 28 months [6] - The CORE-008 trial was initiated to evaluate the combination of cretostimogene and gemcitabine in high-risk BCG-exposed NMIBC patients [5][6] - Anticipated milestones include the completion of Phase 3 enrollment for PIVOT-006 in Q3 2025 and topline data from various trials expected in Q4 2025 and 1H 2026 [4][11]

Core Insights - Genelux Corporation is advancing its late clinical-stage immuno-oncology product, Olvi-Vec, with significant clinical readouts expected in the coming year, particularly for platinum-resistant/refractory ovarian cancer [1][2][4] Pipeline Highlights - The Phase 3 OnPrime/GOG-3076 trial for Olvi-Vec in platinum-resistant/refractory ovarian cancer is on track, with topline data anticipated in the first half of 2026 [5] - Ongoing trials for small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC) are expected to provide important data updates later this year, which may support the systemic delivery program of Olvi-Vec [2][5] Business Updates - The company appointed Eric Groen as General Counsel and Chief Compliance Officer, enhancing its leadership team with over 20 years of experience in the life sciences industry [3][6] - The CEO emphasized the potential of Olvi-Vec to redefine treatment paradigms for recurrent tumors and the company's growth phase [4] Financial Results - For Q2 2025, Genelux reported a net loss of $7.5 million, or $0.20 per share, compared to a net loss of $6.6 million, or $0.22 per share, in Q2 2024 [11][19] - Research and development expenses increased to $4.8 million from $4.4 million year-over-year, primarily due to higher clinical trial costs [10] - General and administrative expenses rose to $3.0 million from $2.5 million, driven by increased salaries and professional services [11] Cash Position - As of June 30, 2025, the company had cash, cash equivalents, and short-term investments totaling $28.1 million, expected to fund operations into Q3 2026 [9]

Cretostimogene Clinical Development and Efficacy - CG Oncology's clinical development strategy targets approximately 70% of the Non-Muscle Invasive Bladder Cancer (NMIBC) market, representing a multi-billion dollar opportunity[10, 49] - In a Phase 3 registrational study for High-Risk BCG-unresponsive NMIBC, cretostimogene demonstrated a potential best-in-class efficacy with a 75% Complete Response (CR) rate at any time[10] - The 12-month Duration of Response (DoR) was 63.5%, and the 24-month DoR was 56.6%, with the median DoR exceeding 27 months and ongoing in the Phase 3 study[10] - In the BOND-003 Cohort C trial, 97.3% of patients were free from progression to MIBC at 12 months[23] - Cystectomy-Free Survival in BOND-003 Cohort C was 90% at 12 months[23] - In BOND-003 Cohort C, 50% of patients reinduced with oncolytic immunotherapy converted to CR, and 64.3% remained in durable response after conversion[28] Safety and Tolerability - Cretostimogene has a favorable safety profile with 0% Grade 3 or higher treatment-related adverse events observed in clinical trials[10, 30] - In the cretostimogene arm, 64.3% of patients experienced any grade of Treatment-Related Adverse Events (TRAEs)[31] Financial and Strategic Outlook - CG Oncology has a strong balance sheet with a cash runway expected into the first half of 2028 to drive commercialization and indication expansion[10] Market and Treatment Landscape - Physicians in top key accounts treat more than 70% of NMIBC patients by volume[46]

RP1 Clinical Trial Results & Opportunities - In anti-PD1 failed melanoma patients, RP1 plus Nivolumab achieved an Objective Response Rate (ORR) of 32.9% and a median Duration of Response (mDoR) of 33.7 months[78] - In responders, responses in non-injected lesions occurred with similar frequency and depth as injected lesions, indicating systemic benefit[78] - Patients with deep/visceral (+/- superficial) injections had numerically higher response rates vs those who received superficial injections only[78] - In solid organ transplant patients with locally advanced CSCC, RP1 monotherapy achieved an ORR of 34.6% and a Disease Control Rate (DCR) of 65.4%[220] - In a study of resectable cutaneous Squamous Cell Carcinoma (cSCC), RP1 monotherapy resulted in a 100% overall response rate, with 83% achieving pathological complete response[214] RPx Platform Expansion & Pipeline - The company is planning RPx expansion into additional skin cancers, liver and thoracic primary/metastatic cancers[174] - A confirmatory Phase 3 trial (IGNYTE-3) is underway in melanoma, randomizing patients to RP1 + Nivolumab vs Treatment of Physician's Choice[179] - A registrational REVEAL study is ongoing for RP2 in metastatic Uveal Melanoma, comparing RP2 + Nivolumab to Ipilimumab + Nivolumab[243] - RP2 is being evaluated in liver primary/metastases, including a cohort with RP2 + Bevacizumab + Atezolizumab in 2L PD-(L)1 failed Hepatocellular Carcinoma (HCC)[246] Commercialization & Market Opportunity - The company estimates ~10,000 addressable patients across lines of therapy for RP1 in the US melanoma market[111] - The company estimates RPx has the potential to reach up to ~125,000 patients in the US across various cancer types[251] - The company has hired and trained a commercial organization of ~60 customer-facing team members[108]

Financial Data and Key Metrics Changes - The company ended the fiscal year with cash and cash equivalents totaling $483.8 million, an increase from $420.7 million at the end of the previous fiscal year [21] - Research and development expenses for the fiscal fourth quarter were $54 million, compared to $42.6 million in the same quarter of the previous year, reflecting increased personnel and consulting costs [22] - The net loss for the fiscal fourth quarter was $74.1 million, compared to a net loss of $55.1 million in the same quarter of the previous year [23] Business Line Data and Key Metrics Changes - The company is preparing for the potential approval and launch of RP-one, which is positioned as a first choice for advanced melanoma patients who have previously received anti PD-one therapy [6][7] - The IGNITE study data indicates that approximately one-third of patients achieve durable responses, highlighting the potential of RP-one in a high unmet need setting [6] Market Data and Key Metrics Changes - The company estimates that approximately 13,000 patients progress on or after PD-one treatment annually in the US, with about 80% eligible for RP-one [12] - The geographic distribution of patients with advanced melanoma allows for targeted launch efforts, focusing on around 350 key accounts that treat half of the melanoma population [15] Company Strategy and Development Direction - The company aims to establish RPX as a new interventional immuno-oncology treatment paradigm, expanding beyond skin cancer [8] - The commercial organization has been built out to support the launch of RP-one, with a focus on interventional radiology and oncology collaboration [17] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming PDUFA date of July 22, 2025, and the potential for RP-one to address significant unmet needs in advanced melanoma treatment [6][41] - The company is actively engaged with the FDA and has completed necessary inspections, indicating no impediments to the approval process [42] Other Important Information - The company plans to host an Investor Day on June 24, where it will discuss the current melanoma landscape and the RP-one roadmap for commercial success [20] - The company has developed a patient support hub, Replimmune Connect Plus, to enhance the treatment experience for patients and caregivers [18] Q&A Session Summary Question: What sort of medical education work are you going to be doing at ASCO ahead of the launch of RP-one? - The company will present important data at ASCO, including response rates for different lesion types and safety data, to build physician confidence in RP-one [26] Question: Can you give us some color around your expectation for the launch trajectory? - The company anticipates broad and rapid adoption of RP-one, with significant training and experience among key accounts by the time of launch [33] Question: Can you discuss the impact you're seeing from the recent regulatory changes? - The company has received breakthrough designation and is on track for the July 22 PDUFA, with consistent engagement from the FDA [41] Question: Can you talk to your expectations on the potential label for RP-one? - The company expects the label to reflect the broad population studied in the IGNITE trial, which included various anti PD-one failed presentations [52]

Summary of CG Oncology Conference Call - May 03, 2024 Company Overview - **Company**: CG Oncology - **Product**: Credo Simogene (an investigational oncolytic immunotherapy) - **Indication**: Treatment of high-risk BCG unresponsive non-muscle invasive bladder cancer (NMIBC) Key Points and Arguments Clinical Trial Results - **BOND-three Trial**: Phase III registrational study evaluating Credo Simogene - **Complete Response (CR) Rate**: - 75.2% CR at any time for 105 evaluable patients, maintaining from 75.7% in December 2023 [6][23] - 79 complete responders reported, the highest number in this indication [23] - **Durability of Response**: - 83% of patients maintained CR for over 12 months [24] - 54% of initial non-responders converted to CR after a second induction [13][43] - **Safety Profile**: - No Grade 3 or higher adverse events reported [14][25] - 94.5% of patients completed all protocol-mandated treatments [25] Mechanism of Action - **Dual Mechanism**: Designed to replicate in and kill cancer cells while inducing antitumor immunity [8] - **Oncolytic Immunotherapy**: Mechanism supports the observed efficacy and safety [26] Comparisons with Other Therapies - **Efficacy Comparison**: - Credo Simogene's 75.2% CR rate compares favorably to: - 62% for combination therapy with MEO3 and BCG - 51% for Nadopiragine - 41% for Pembrolizumab [16] - **Safety Comparison**: - No Grade 3 or higher treatment-related adverse events, positioning Credo Simogene as a potentially safer option [14][16] Regulatory Designations - **FDA Designations**: Fast Track and Breakthrough Therapy designations granted for Credo Simogene [18] Trial Amendments and Future Studies - **New Cohorts**: Introduction of a treatment extension phase for complete responders and a new high-grade papillary cohort (Cohort P) [19] - **Expanded Access Program**: Designed to enhance geographic and ethnic diversity in patient data collection [20] Market Insights - **Target Patient Population**: - The prevalence of high-risk patients is estimated to be at least twice the incidence population [77] - **Therapeutic Landscape**: - Patients typically receive 2 to 4 lines of therapy after BCG treatment [79] Manufacturing and Logistics - **Manufacturing Process**: No changes to the robust process used in the Phase III trial, ensuring a lower risk profile for commercial launch [51] - **Cold Storage and Shipping**: Credo Simogene will be shipped in a just-in-time manner at -50 degrees Celsius, with a preparation time of 10 minutes [53][54] Additional Important Points - **Patient Demographics**: Most patients were white, male, and of Medicare age, with a median age of 73 [12] - **Physician Feedback**: High enthusiasm from urologists regarding the results, particularly appreciating the simplified installation process [29][32] - **Reinduction Acceptance**: Reinduction is a common practice in BCG therapy, and the results from Credo Simogene support this approach [42][45] This summary encapsulates the critical insights and data presented during the CG Oncology conference call, highlighting the efficacy, safety, and future potential of Credo Simogene in treating high-risk NMIBC.